Tag Archives: controversy

In the Part 1of Home birth: Smart choice or risky business? we analyzed the issues of personal satisfaction, maternal safety and baby’s risks. Part 2 dealt with hospital transfers, water birth and the situation in the Netherlands. Check out the last three reasons women choose home birth, and read the final conclusion to decide whether home birth is a clever or a dangerous option…

7) “Home birth is cheap”

Home birth is cheaper… provided that no transfer is needed and nothing goes wrong

Cost-effectiveness is an important issue in every country with an organized health system. Countries like England or the Netherlands, where the National Health System (NHS) covers the cost of deliveries, have calculated that is cheaper that women deliver at home, avoiding a more expensive hospital admission. For example, the UK NHS “prices” home birth £1066 and birth at a hospital £1631. The economical factor is one of the reasons certain professional organizations support home labor, such as the Royal College of Obstetrics and Gynaecologists (RCOG) which states that: “home birth is the most cost-effective place for delivery”.

But this cost analysis has been challenged, as it does not take in consideration the high transport rates; in fact, a Dutch report calculates a general 3-fold increase of costs in patients transported during labor, when the costs of the midwife, the transport system, the obstetrician and the hospital are included. In addition, the costs derived from the maintenance of an adequate transport system (ambulances and trained staff) should not be neglected. Assuming increased neonatal risks, admissions to the neonatal intensive care unit, the lifetime costs of supporting neurologically disabled children and potentially increased professional liability costs resulting from a complicated home birth can potentially inflate the costs.

Indicative of these unexpected expenses is the article Home birth: What the hell was I thinking? A journalist from The Guardian went on a mission following a home birth. After managing to deliver her child at home, both the woman and her baby had a complication and needed to be transferred to a hospital. Since the baby and the mother were not allowed to be in the same ambulance, two ambulances were required…

Regarding the costs arising from a private home birth, the situation varies in different countries; in the USA home births are not covered by health insurances, and a couple is expected to pay $1500 to 4500 to the midwife. Hospital births can range from $3,296 to 37,227, although they are usually covered totally or partially by the insurance. Of note: adoctor gets paid about $2500-4000, same as a midwife. Ιn Europe, a couple is expected to pay about 2000-3000 €; recently the Italian newspaper La Stampa published the article Home birth: a 3000 € luxury that does not convince doctors.

Indeed, Mother nature is great. If you think about it, the whole process of labor and delivery seems to be so perfect, almost magical… But “natural” is not a synonym of “risk-free”. Sometimes Mother nature can play strange games. We may believe we have everything under control, but things may flip just in a second: think earthquakes, or tsunamis… Exactly the same thing applies to childbirth: even when someone seems to be “low risk”, disaster can strike without any warning …

“Childbirth is inherently dangerous,” writes in her blogAmy Tuteur, an American obstetrician gynecologist. “In every time, place and culture, it is one of the leading causes of death of young women. And the day of birth is the most dangerous day in the entire 18 years of childhood”. Finally, she adds: “Why does childbirth seem so safe? Because of modern obstetrics. Modern obstetrics has lowered the neonatal mortality rate 90 per cent and the maternal mortality rate 99 per cent over the past 100 years.”

The absolute confidence in a woman body’s ability to deliver is expressed bysupporters of unassisted childbirth (UC), the “hard core” version of home birth, which, although practised already since the 70s, it has lately seen a resurgence. Also known as freebirth, DIY (do-it-yourself) birth, unhindered birth, or unassisted home birth, it refers to women that intentionally deliver without the assistance of a physician or midwife; they may be completely alone (“solo birth”) or assisted by a lay person, such as the spouse, family, friend, or a non-professional birth attendant. There are no data on safety of UC, except that coming from a religious group in Indiana (USA) that found a perinatal mortality rate 2,7 times higher, and a maternal mortality rate 97 times higher than the state average.

Among the most famous UC advocates is Janet Fraser who, ironically, lost her baby after five days of home labour; in spite of that she continues to advocate for freebirth. In fact, UC is not endorsed by any scientific organization, as it is considered too dangerous. According to André Lalonde, executive vice-president of the Society of Obstetricians and Gynaecologists of Canada (SOGC):“Freebirth is the equivalent of playing Russian roulette with your child”.

9) “I have the right to deliver wherever I want”

A home birth oxymoron: right to privacy vs. social media exposure

This is a very complex issue with ethical and legal connotations, which has originated intense debate among experts. Even scientific organizations differ in their recommendations. For example, The American College of Obstetricians and Gynecologists, until recently opposed to home births, has decided to temper its position: “…hospitals and birthing centers are the safest setting for birth, but it respects the right of a woman to make a medically informed decision about delivery.” On the other side, the American College of Nurse-Midwives (ACNM) maintains that “every family has a right to experience child birth in an environment where human dignity, self-determination, and the family’s cultural context are respected” and that “every woman has a right to an informed choice regarding place of birth and access to safe home birth services”. Let’s analyze the ethical and legal aspects of home birth:

Ethical issues

These are some of the ethicals dilemmas related to home birth:

Mother vs child safety. Although hospital birth seems to increase maternal interventions in all studies (apparently without increasing severe risk), the baby’s safety remains a subject of debate; taking though in consideration all the studies, there seems to be increased risk for the baby. Let’s take for example the Birthplace study (which is in somewhere in the middle). This study found that, particularly for first time mothers, the baby’s risk is 3 times higher (of which more that half of the cases are death and brain damage). Is it ethically acceptable for a woman to value her birth experience over her baby’s welfare? Is maternal emotional wellbeing so important to justify risking the baby’s health?

Respect for dignity and privacy. “Dignity” may have a different meaning for each person. Some home births supporters feel that the presence of a doctor and the hospital staff make them feel “degraded”; moreover “for some women the possibility of the loss of privacy is a major issue, because privacy is a valued possession”.

Is it not contradictory that so many women, zealous advocates of home birth and their right to privacy, do not hesitate to publish their home birth photographs and videos -some of them with incredible details- in every social media site, where they are exposed to the eyes of millions of people?

Self-determination. In order to make truly informed decisions about childbirth options, women need to be informed of what they are and have the possibility to discuss them. Is it ethical to offer the option of home birth knowing that there is increased risk for her baby?

In theory, the person informing the pregnant woman should inform her objectively and avoid being paternalistic. The problem is that, informed decision-making implies accurate assessment of risks and benefits, but the safety of home birth remains debatable. Is it possible to inform objectively a pregnant woman about home birth? Or the information will be biased according to the health care provider beliefs or experiences?

Other possible ethical issues:

In the home birth situation, are a woman’s reproductive rights and medical responsibility incompatible with each other?

Where do a woman’s rights end and medical responsibility begins, especially considering that the physician is also responsible for the baby’s welfare?

In case of a baby adverse outcome that could have been prevented in a hospital setting, what will be the psychological consequences for the couple?

What is the psychological burden of a home birth in a family’s older children witnessing a home birth? What if a complication occur in their presence?

In Europe, the European Court of Human Rights (ECtHR) ruled in 2010 that Hungary had violated Article 8 of the European Convention on Human Rights (ECHR) because it had interfered with a woman’s right to choose where to give birth. Ms Ternovszky wanted to give birth at home but argued that she was prevented from doing so because a government decree dissuaded health care professionals from assisting home births. This case was the first decision by an international human rights organization on the right to choose the circumstances of giving birth, and was heralded by home birth advocates across Europe.

However, in a recent case against the Czech Republic, the Human rights judges decided that national authorities of each country has “considerable room for manoeuvre” when regulating home births, a matter for which there is no European consensus and which involves complex issues of health-care policy as well as allocation of State resources.

So, is home birth a smart choice or a risky business?

As an obstetrician who supports natural birth, I hear many times the women’s complaints about the excessive medicalization of childbirth. And I feel that sometimes they are right. However, being a mother myself, I never regretted my choice of a hospital birth for my children. After having helped so many women deliver their babies, I have seen many times complications that were totally unpredictable. Occasionally, these sudden complications are so serious, that we have to run -literally- from the delivery room to the operating room to save the baby or the mother! Therefore, even when having skilled professionals attending your home birth, even in countries with very organized structures, the distance to a hospital can prove fatal. Is for this reason that, in my opinion, a hospital birth is without any doubt the best choice for every woman. A birthing center attached to a hospital may also be a good choice.

True, the studies results are controversial, but for me “almost as safe as a hospital birth” is not enough to make me change my mind.

True also, a hospital birth is related to more epidurals, cesarean sections, instrumental deliveries and episiotomies. Regarding the epidural, if you can do it without one, that’s great! But sometimes labor pain is unbearable, and it’s not uncommon to see women without any pain relief who, when the moment to push comes, they are so exhausted and their pain is so overwhelming that they literally lose it. On the contrary, women with an epidural can be more focused and relaxed. The bottom line is: natural birth is not for everybody. And women don’t have to feel guilty because they chose to have an epidural. It’s better to have nice memories of your birth, and for that the epidural can help!

Whether too many cesareans sections are being done is a topic more controversial than home birth itself, and it would deserve a separate article. But what I can say is that, when cesarean sections are done in a judicious way by a conscious physician, they can save your life and your baby’s life. Since hospital births result in better neonatal outcome, it is clear to me that mostinterventions are an inevitable trade-off to save more babies or to avoid severe damage. The same goes for the controversial fetal monitoring, which may lead to more cesarean sections, it may not decrease perinatal mortality, but it reduces by 50% the risk of brain damage. Personally, I would do anything in my power to reduce the chances of having a brain damaged baby.

Of course, a lot that should be done -and can be done- to improve hospital birth: create home-like conditions to help women be relaxed and empowered, allow women to walk during labor, give them possibility to push and deliver in any position they wish, avoid unnecessary interventions such as systematic episiotomies, etc. I believe that some efforts are slowly being done worldwide, but we still have a long way to go!

In conclusion, a woman has the right to choose where to deliver; however, until the risks are clarified, maternal wellbeing may undermine the child’s welfare. Therefore, in my opinion, a natural hospital birth is the safest choice. Natural hospital birth IS possible!You just need motivation and a supportive team…

Hospitals should increase their efforts to provide women with a friendly environment so they can deliver their babies in comfort and total safety. Every baby is precious, every mother is precious!

In the first part of this article we analyzed three important issues related to home birth: personal satisfaction, the mother’s safety and the baby’s risks. Check out the next three reasons women choose a home birth…

4) “I plan to have a home birth, but if something should happen I will go to a hospital”

Even when properly prepared for a home birth, transfer to a hospital is commonly required

As previously mentioned, hospital transportation is a common event: about 1 out of 2 first time mothers and 2 out of 10 second or subsequent time mothers need to be transferred to a hospital; moreover, hospital transfer is almost always perceived by the couple as a negative and disruptive experience (see part 1).

The need for transportation to a hospital can occur before, during of after birth, and can be related to the mother, the baby or both. The top reasons may vary in different countries, although prolonged labour is the first cause of transfer in almost every study, followed by pain relief or the midwife’s unavailability at the onset of labor.

Maternal and fetal necessity for transport is often impossible to predict.

For unpredictable, extremely sudden complications, even rapid transport may not prevent the baby or the woman from death or severe harm, such as shoulder dystocia, sudden cardiopulmonary arrest, or maternal exsaguination (bleeding to death, read Caroline Lovell story here).

Women with severe hemorrhage may already be in shock when arriving at a hospital. Even though the adequate treatment can be immediately instituted, death may nevertheless occur.

Perinatal mortality is higher when transport to the hospital is required.

5) “At home I can have a water birth”

The latest years there has been an increasing demand for water birth

Immersion in water during labor and delivery, although available for several decades, has seen a greatly renewed interest the latest years. In fact, even certain hospitals and birth centers have incorporated birth pools to their facilities. The results of studies analyzing maternal and fetal benefits and risks of water birth are inconsistent, and many times contradictory. The American College of Obstetricians and Gynecologists (ACOG) has just reviewed the subject and a few days ago (November 2016) published an updated statement. What are then the proposed pros and cons of water birth?

For the baby. Supporters of water birth believe that the transition to the outside world is less traumatic for babies born in water as the warm water of the pool may feel like the amniotic fluid; thus water-born babies are supposedly calmer than babies born in air. In fact, no benefits for the newborn were found withmaternal immersion during labor or delivery, neither in 2 systematic reviews including 12 studies and 29 studies respectively, neither in the 2009 Cochrane systematic review, or any individual trials included in ACOG’s review.

The risks

For the mother. ACOG’s review did not find increased risk for maternal infections or postpartum hemorrhage. However, this conclusion must be tempered by the lack of data on rare serious outcomes, such as severe morbidity and mortality.

For the baby. Most studies found that immersion during labor does not increase fetal or neonatal risk. However, concerns have been expressed that immersion during delivery may predispose the infant to potentially serious neonatal complications. Several studies have reported several serious adverse outcomes among neonates delivered in water, these include :

Infection: cases of severe infections with certain bacteria, mainly Pseudomonas aeruginosa (here, here) and Legionella pneumophila (here, here, here, here) have been observed, some of which were fatal. The bacteria causing infections my come from the woman’s body, the water or the pool itself. Recently, a fatal infection by a virus (adenovirus) was reported in a baby born from a mother with gastroenteritis giving birth in a pool.

Water aspiration (drowning or near-drowning): it has been claimed that babies delivered into the water do not breathe or swallow water because of the protective “diving reflex”; however, it has been demonstrated that in compromised newborns the diving reflex is overridden, leading to gasping and aspiration of water. Actually, it seems that even healthy babies may be at risk of water aspiration, which may result in hyponatremia and seizures.

Umbilical cord avulsion(cord “snapping” or cord rupture): this complication may happen in 1 out of 288 water births and occurs when the baby is lifted out of the water; in some instances the affected newborns have required intensive care unit admission and transfusion.

Unpleasant environment: women may feel uncomfortable about accidentally defecating in the pool; which, as stated above, may also predispose the baby to severe infections.

Disappointment with pain relief: for some women, immersion in water is not enough to relieve pain.

Monitoring and emergencies: it may be difficult to quantify blood loss (see photo); in cases of concern about the baby’s heartbeat, monitoring may be difficult; moreover, in the event of a severe maternal complication (such as fainting or heavy hemorrhage) it may be difficult to move the pregnant woman out of the water.

Several professional organizations, including the Royal College of Obstetricians and Gynaecologists and the American College of Nurse–Midwives, support healthy women with uncomplicated pregnancies laboring and giving birth in water. According to ACOG, immersion in water during the first stage of labor may have benefits for the mother and may be offered to healthy women with uncomplicated pregnancies; however, there are insufficient data regarding the relative benefits and risks of immersion in water during the second stage of labor and delivery. Therefore, until such data are available, “it is the recommendation of the American College of Obstetricians and Gynecologists that birth occur on land, not in water”. The British National Institute for Health and Care Excellence (NICE) recommendations are in agreement with the ACOG.

6) “In the Netherlands women have been delivering at home for more than fifty years”

The Netherlands has the highest percentage of home births in the Western world

The Netherlands is a country with a long tradition of home birth, with well-trained midwifes, organized transport system and short distances to hospitals. However, it is one of the few countries in the world where the incidence of home births is decreasing: in 1965, two-thirds of Dutch births took place at home, but that figure has dropped to about 20% in 2013. Moreover, Dutch women have to pay an extra amount (around €250) when deciding for a “nonindicated hospital birth” under the guidance of an obstetrician or a midwife (here). According to Professor Simone Buitendijk, head of the child health programme at the Netherlands Organisation for Applied Scientific Research, “… home birth rates have dropped like a stone. Soon, there will not be enough demand to justify the infrastructure” she says. “Then the system will collapse – and let there be no misunderstanding: we won’t be able to rebuild it”.

This drop in home births seems to be related to the increasing awareness of the media, patients, and obstetricians about the risks of home birth (here). Even more skepticism originated the results of the Euro-Peristat study: the Netherlands is one of the countries with the worst perinatal outcomes of Western Europe.

Home births have been, for a long time now, the subject of endless controversy and polarized discussions among physicians, midwives and strongly opinionated women. Indeed, the idea of giving birth at home sounds attractive. With the growing interest for an “all natural” lifestyle, natural home birth looks like a logical way to go. What’s more, celebrities are doing it, and midwives are becoming a status symbol!

Even mass media has embraced the trend: since 2008, when the documentary The business of being bornwas aired in the USAmany women were “converted” to fanatic home birth supporters. This documentary follows a New York midwife who delivers babies at home, while it “uncovers” -what they consider- the major business childbirth has become for doctors and hospitals. In the UK, the series Call the midwife, with its empathetic view of midwives have experts hoping that “it will spark a resurgence in home births…as women see the holistic care that midwives can deliver”.

And all this “campaign” seems to have worked! Home births have seen a considerable increase in many countries, including the USA, Canada, UK and Australia.

So why the fuss about giving birth at home? Why do women want to deliver like in the 1900s? The answer to these questions is not straightforward…

While reviewing the bibliography on home birth, I realized how massive the amount of information on this subject is, both in scientific and lay sites, and how contradictory it becomes sometimes…

If you are considering home birth, check out this article where I analyze the reasons women choose to have their child at home. In order to simplify reading, I divided it in three parts; read all three so that you can make your responsible and educated choice.

1) “A delivery at home is a wonderful experience”

There is no doubt that birth is a unique, life-changing experience for every woman, and no one can deny the importance of the emotional and psychological aspects of a bringing a child to the world. As mentioned earlier, the reasons women choose a home birth are many: some women feel that the privacy of their home will make them feel more comfortable, less stressed out, and with more control of their own labor. Others find that being surrounded by friends, relatives, or their older children is of utmost importance. Finally, many woman choose home birth out of curiosity, as they have heard so many stories about amazing, empowering, ecstatic, or even “orgasmic” home births. Actually, personal satisfaction seems to be the main reason women want to deliver at home.

But is home birth always this pleasurable, fantastic experience women expect? Unfortunately, this is not always the case. According to Birthplace, a recent British study, a high percentage of women will need a hospital transfer: up to 45% of first-time mums (nulliparous) and 13% of second and subsequent time mothers (multiparous) were transferred to a hospital. Similar figures are reported in the Netherlands, a country with a long tradition of home birth: 49% of primiparous and 17% of multiparous women are transported during labor. Most of the times, transfer to a hospital is not a great experience for the couple, as their expectations for a home birth are not fulfilled; this has been uniformly demonstrated by several studies from different countries (such as Sweden, Netherlands and Belgium). Moreover, a Dutch study evaluating women’s views of their birth experience 3 years after the event revealed persistent levels of frustration, including serious psychologic problems,in transported women compared with those who delivered at a hospital.

There is another fact we should not ignore: labor is inherently painful. Even though at home women may be more comfortable and this may result in less pain, sometimes it may be impossible to cope with pain and an epidural may be necessary. Pain relief is actually one of the most common reasons for transport to the hospital, since pain can become overwhelming, In fact, a recent study showed that inability to control labor pain may increase the risk of developing postpartum depression.

2) “Home births are safe for the mother”

Home births result in less interventions, including pain relief…

Besides personal satisfaction, another common reason women choose home birth is because it’s less invasive. The dreadful “cascade of events“, that is, one intervention leading to another during a hospital birth fills with terror most home birth supporters. Indeed, almost every study shows that home births are associated with less interventions as compared to hospital births. The term “interventions” includes: epidural anesthesia, ventouse or forceps delivery, cesarean section and episiotomy (see also here, here and here).

Another controversial intervention that has gained a bad reputation among home birth supporters is continuous fetal monitoring, as they think that it is not needed, it gets in the way of the natural birthing process and it increases interventions such as cesarean section and forceps delivery. But what is the scientific evidence on this subject? According to a Cochrane review, the use of fetal monitoring increases the cesarean delivery rate, vacuum and forceps operative vaginal delivery; in addition, fetal monitoring does not seem to reduce perinatal mortality, neither cerebral palsy risk; however, it reduces by 50% the risk of neonatal seizures, that is, ofbrain damage.

But while some women may experience fetal monitoring, episiotomy or vacuum delivery as a traumatic experience, others may not get particularly bothered by an episiotomy -and many will feel blessed by the epidural “intervention”. So maybe a more important question is: What about severe maternal complications and maternal deaths? In regard to this matter, there is not much information, and the studies’ conclusions are contradictory. A Dutch study looked at “severe acute maternal morbidity” (such as admission to intensive care unit, uterine rupture, blood transfusion, etc) and found that women who delivered their first baby at home had the same risk with women delivering at a hospital, but parous women had increased risk of postpartum hemorrhage and blood transfusion when delivering at a hospital; however, another study, also from the Netherlands, did not confirm these findings. Therefore, a hospital birth leads to more interventions, but it does not seem to increase the risk of serious maternal complications. Regarding maternal deaths, they are a rare event; thus it is not possible to draw conclusions from the studies.

There is something that every woman considering home birth should understand: the studies results apply only to very low-risk pregnancies. Higher risk women, such as those with twin pregnancies, previous cesarean sections, prematures, post term pregnancies, were excluded from most studies, although it is no secret that they are also having home births (it’s easy to realize it just by checking the social media…). It is certain that for these women the risks is much higher, not only for them, but also for their babies.

3) “Home births are safe for the baby”

A healthy baby and a healthy mother are supposed to be a birth’s ultimate goal…

Studies analyzing the baby’s risk yield completely different results according to the country they were done, but they also differ in different areas of the same country, or according to the scientist analyzing the data! In here, I mention the most important studies evaluating neonatal risk by country of origin:

Canada: A recent study showed that planned home birth was not associated with a difference in serious adverse neonatal outcomes as compared to hospital births (Hutton et al, 2016). This study was limited to the Ontario area, had very strict inclusion criteria and high transport rates (see below).

The Netherlands: The Netherlands are usually considered the “gold standard” due to their long tradition in home births. In 2009, de Jonge showed that home birth does not increase the risk of perinatal mortality and severe perinatal morbidity among low-risk women. However, some aspects of this paper may have underestimated the risk (e.g., paediatric data on intensive care admissions was missing for 50% of non-teaching hospitals, among others). In fact, a subsequent Dutch study showed that infants of pregnant woman at low risk under the supervision of a midwife had 2,3 times higher risk of perinatal death than infants of pregnant women at high risk under the supervision of an obstetrician. Moreover, infants of women who were referred by a midwife to an obstetrician during labor had a 3,66 times higher risk of delivery related perinatal death than women who started labor supervised by an obstetrician (See below for more details on home births in the Netherlands).

England: A 2011 large study, the Birthplace study showed that, for low-risk women, home birth had 60% higher chances of “baby events”. The events included death (13%),neonatal encephalopathy (brain damage due to lack of oxygen, 46%), meconium aspiration syndrome (the baby swallows stools, a sign of suffering, 30%), brachial plexus injury (damage of the nerves of the arm, 8%), fractured humerus or clavicle (4%); if the analysis was restricted only to nulliparous women, this risk was almost 3 times higher. For multiparous women (2 or more children), there were no significant differences in the incidence of adverse outcome by planned place of birth.

Australia: in a paper by Kennare et al, although there were no differences in perinatal mortality, home birth was associated with 7-times higher risk of intrapartum death, and 27-times higher risk of death from intrapartum asphyxia (lack of oxygen).Interesting enough, one of the authors (Dr. Keirse) was the chairperson of the working party that developed the Policy for Planned Birth at Home in South Australia.

USA: The largest American study comparing home and hospital births was published in 2013, including data on more than 13 million births. This study indicated that babies born at home are 10 times more likely to be born dead and have almost 4 times higher risk to have neonatal seizures or serious neurological dysfunction (that is, brain damage) when compared to babies born in hospitals. Moreover, the risk of stillbirth inwomen delivering their first baby at home was 14 times the risk of hospital births. Dr. Grunebaum, one of the authors, explains that most likely the risks are even higher than that: “… the outcomes for patients whose care began out of the hospital but were then transferred to the hospital due to complications are reported as hospital deliveries. If the data were corrected, the risk of out-of-hospital delivery is likely to be much greater.” Another American study confirmed these findings, which, contrary to the British study, showed that the neonatal outcome was worse both for nulliparous and multiparous delivering at home.

Pooled data from USA, Australia, Switzerland, Netherlands, Sweden, Canada & UK: A study by Wax et al. showed that home births are associated with a risk of neonatal death three times higher as compared to hospital births. The results of this study led the reputed medical journal The Lancet to write an editorial stating “Home birth: proceed with caution”. Wax’s study though was highly criticized on methodological grounds.

Why such a disparity in the results of the different studies?

There are many possible explanations:

The lack of randomized trials, as it is not possible to force women to deliver at home or at a hospital against their will. It is clear from different studies that women delivering at home are different from those delivering at hospitals (usually home birthers are more educated and come from a more socioeconomically advantaged area); populations may also differ from country to country.

Underreport. In many home births studies there are missing data; in others home births that were transferred to hospitals are included in the hospital group.

Midwives’ training. In most European countries and Canada, home births are attended only by midwives or physicians; midwives have a university degree and undergo intensive training. In most states of the United States, besides certified nurse midwives (with formation equivalent to European midwives), births are also attended by “direct-entry midwives” with no university degree and diverse training; the only requirement for them to practice is a high school degree.

Eligibility criteria for a home birth. Studies with good outcome had very strict inclusion criteria for home birth, that is, they excluded women with twin pregnancies, preterm labor, preeclampsia, etc.

Transport rates. Best outcome was associated with a very high transportation rate: about 40-50% for nulliparous, 10-20% for multiparous. On the contrary, the US studies -with more adverse results- report overall transportation rates of about 10%.

Efficiency of transport system, midwives’ integration to hospitals. Rapid availability of ambulances -such as the so-called Obstetric flying squad in the UK- and hospitals in tight collaboration with midwives working in the community seem to be essential. But even so, some complications may not be solved, even by the most efficient form of transport.

Distance to the hospital. Although shorter distance to hospital seems to be crucial, even this may not prevent certain complications. Hospitals have what is called the “decision to incision” rule, that is, the maximum time that should pass between the decision to make an emergency cesarean section and the time it is actually done. This rule is 20 or 30 minutes, according to different countries. It is clear that this time frame cannot be achieved with home birth, not even with close distance to a hospital.

The HPV vaccine has been around for almost 10 years and more than 175 millions doses have been distributedin 63 countries, with several studies confirming its safety and efficacy. In spite of that, the vaccine still remains a subject of controversy. Although recommended by most scientific societies worldwide, some recent reports questioning its safety fuelled even more the debate, dividing both general public and medical community.

In this article we will analyse the existing evidence regarding the HPV vaccine, with particular focus on its efficacy and safety. In order to organise the available information, the article will be divided into the following sections:

Getting to know HPV

Why a vaccine? The burden of HPV-related diseases

The three available HPV vaccines

Vaccination schedule and timing

Efficacy of the HPV vaccine

Safety of the HPV vaccine

Recent safety concerns: the chronicle of events

Other debatable issues

Unanswered questions…

Conclusion

1. Getting to know HPV

HPV (human papillomavirus) is a virus and is transmitted from person to person through skin-to-skin contact.

HPV infection is extremely common, and most of the times it will be cleared by the immune system.

Of the over 100 types of HPV, about 12 subtypes of the HPV (mostly subtypes 6 and 11) may cause genital warts (also known as condylomas). These so-called “low-risk types” can also cause a rare condition called recurrent respiratory papillomatosis, in which warts grow in the throat.

Approximately 15 types of HPV (most commonly types 16 and 18) are related to cancer. While cervical cancer is the most common HPV-related cancer, this virus can also cause other cancers: vulvar, vaginal, anal and oropharyngeal (mouth and throat), as well as penile cancer in men.

2. Why a vaccine? The burden of HPV-related diseases

These figures will give you and idea of the magnitude of the problems caused by HPV:

-Worldwide, over 500,000 new cervical cancer cases are diagnosed annually. Cervical cancer ranks as the 4th cause of female cancer in the world and is the 2nd most common female cancer in women aged 15 to 44 years (1).

In the United States, an estimated 26,000 new cancers are attributable to HPV each year, about 17,000 in women and 9,000 in men (2) .

In Europe, about 58,000 new cases of HPV-related cancers are estimated to occur every year (3).

-Regarding precancerous lesions, the estimated annual burden of high-grade precancerous lesions ranges between 280,000 and 550,000 new cases per year in Europe (4).

-In addition to cancers and precancerous lesions, the problem of genital warts should also be taken into consideration. Genital warts are very common: 1 out of 10 persons will have condylomas at some point in their lives (the frequency varies according to different countries between 0,3 and 12 %) (5). About 800,000 new annual genital warts cases are estimated to occur in women and men in Europe (4). Although not life-threatening, the costs derived from their treatment and their psychological burden should not be neglected.

3. The three available HPV vaccines

From 2006, 2 vaccines have been available: One bivalent (Cervarix®), directed against HPV types 16 and 18, responsible for about 70% of cervical cancers and other HPV-associated cancers; the other quadrivalent (Gardasil® of Silgard® in different countries) containing 4 HPV types:16 and 18, together with HPV 6 and 11 which are responsible for more than 90% of genital warts.

In December 2014, the American Food and Drug Administration (FDA) approved a nine-valent vaccine, Gardasil 9® (6), which, besides the 4 strains contained in Gardasil (i.e., 6,11,16,18), includes types 31, 33, 45, 52, and 58, responsible for an additional 20% of HPV-related cancers (4). Gardasil 9 has also been recently approved for commercialisation in Europe (7).

4. Vaccination schedule and timing

Vaccines are given as a 3-dose series, Gardasil at 0, 2 and 6 months, Cervarix at 0, 1 and 6 months (8).

In the States, The Advisory Committee on Immunization Practices (ACIP) and the American College of Obstetrician and Gynecologists (ACOG) recommend that girls be routinely vaccinated at age 11 or 12 years.

Since 2010 boys have been included in the vaccination schedule in the USA, with the same schedule as girls.

If not vaccinated when they were younger, girls/young women and boys/young men should be vaccinated through age 26 (9).

A reduced, 2-dose schedule is recommended by the World Health Organization (WHO) for those aged 9-13years; this schedule is not recommended by the ACIP but it has been adopted by many countries.

Earlier vaccination (before age 14) results in higher immune response. Another argument in favor of early vaccination is the fact that vaccines are more effective before the onset of sexual activity (8).

Vaccination is recommended regardless of sexual activity or known HPV infection. Although vaccines seem to be less effective in sexually active people, some benefit is expected to be attained since exposure to all types of HPV included in the vaccines is very unlikely. Testing for HPV is NOT recommended before vaccination.

The vaccines are prophylactic, that is, they do not prevent progression of existing infection to disease or treat existing disease. (2)

The HPV vaccine is covered by most private health insurance and government insurance programs worldwide. Vaccinations schedules may vary in different countries.

There seems to be additional protection by the vaccine in women through age 45, as showed by certain studies (11). However, there is no recommendation for vaccination in individuals aged 26 to 45.

The same schedule applies for Gardasil 9 (0, 2 and 6 months). Revaccination with the nine-valent vaccine is not recommended in persons who previously completed the three-dose series with the bivalent or or quadrivalent HPV vaccine (8).

5. Efficacy of the HPV vaccine

The ultimate goal of the HPV vaccine is to reduce the incidence of HPV-related cancers. For obvious ethical reasons, the endpoint set to evaluate the HPV vaccine efficacy in different studies was precancerous lesions, namely CIN 2 and 3 (high risk lesions of the cervix, with potential to evolve to cancer). Other efficacy endpoints evaluated were incidence of HPV infection and incidence of condylomas.

Studies conducted before licensure showed that both vaccines achieved a high level of protection: 98-100% for the HPV types included in the vaccine in a naive population (that is, women who did not have HPV 16 or 18 at the time of vaccination), although the protection against precancerous lesions was 30-40% in the total vaccinated cohort (which included women who did not finish their immunization plan, or that were already infected with the virus before vaccination) (12, 13, 14, 15). There was also cross-protection for other types of HPV (i.e., HPV 45 and 31), which was more intense with Cervarix (16).

The impact of vaccination on the general population has also been analysed in some studies. Australia was the first country to introduce an organised HPV vaccination program, achieving one of the world’s highest vaccination compliance rates. Since 2007, when the National HPV vaccination program started with the quadrivalent vaccine, HPV infections from the types included in the vaccine decreased from 29% to 7% (17); a 93% reduction in the diagnosis of genital warts was also observed (18). Moreover, other recent studies showed an almost 50% reduction of high-grade cervical precancerous lesions in women who had received all required doses of the vaccine (19).

Denmark also counts with an organised vaccination program. Six years after licensure of the quadrivalent HPV vaccine, a reduction of cervical precancerous lesions was observed, which was 80% in younger patients (20).

Recently, a study was conducted to evaluate the efficacy of the nine-valent vaccine. Gardasil 9 prevented 97% of high-grade precancerous lesions of the cervix, vulva, and vagina caused by the five new high-risk HPV types (HPV31/33/45/52/58) (21). The nine-valent vaccine also generated immune responses to HPV6/11/16/18 that were as good as or better than those generated by the quadrivalent vaccine. (4, 22)

6. Safety of the HPV vaccine

Many studies have evaluated HPV vaccine safety, both before their commercialisation and post-release, which demonstrated no differences in side effects as compared to control groups, irrespective of age and ethnicity (23).

According to the CDC, the most commonly reported side effects of the vaccines are:

Pain, redness, or swelling in the arm where the shot was given

Fever

Headache or feeling tired

Nausea

Muscle or joint pain

Fainting (also known as syncope) and related symptoms (such as jerking movements) is not uncommon (24), especially in teenagers. For that reason, it is recommended that people receiving the HPV vaccine sit or lie down during vaccination, and remain seated for 15 minutes after the shot. (23)

Considering the target age of vaccination (which includes women in reproductive age), pregnancy outcomes received special attention. Noincrease in miscarriage rates has been reported for either of the vaccines (25). In addition, pregnant women that were recorded and observed in registrative trials did not have increased rate of congenital abnormalities (26, 27, 24).

Studies have also demonstrated efficacy and safety of the vaccines in men, both in heterosexual and men who have sex with men (28).

Serious side effects are very rare (less than 0.5%) (29), the most common being persistent headache, hypertension, gastroenteritis, bronchospasm and anaphylaxis. Their reported incidence is similar to that of other compulsory vaccines types (30).

Certain side effects have been a matter of concern since the introduction of the vaccine, namely autoimmune diseases (AD) (i.e., hypothyroidism, rheumatoid arthritis, Behçet’s syndrome, Raynaud’s disease, type 1 diabetes, and vitiligo), neurological disorders (such as epilepsy, paralysis, Guillain–Barré syndrome, central demyelination, and multiple sclerosis) and venous thromboembolism (a blood clot that plugs a vein). It should be mentioned that ADs are not rare in adolescents and young adults, particularly in women. Therefore, it is a real challenge to distinguish causal from temporal association. A recent study gathered the results of 9 large studies (of which one was an analysis of 42 trials together, or metanalysis) in order to investigate severe adverse reactions after the HPV vaccine. None of the included studies found evidence of increased risk of autoimmune disease, neurological disorder, or venous thromboembolism (31).

The Global Advisory Committee on Vaccine Safety (GACVS), established by the World Health Organization (WHO) provides independent, scientifically rigorous advice on vaccine-safety issues. In December 2013, the committee reviewed different topics and considered all available evidence on the safety of HPV vaccines, and concluded that both commercially available vaccines are safe (32). Likewise, the International Federation of Gynecology and Obstetrics (FIGO) Gynecologic Oncologic Committee and Subcommittee for Cervical Cancer Prevention support the continued administration of the HPV vaccines in appropriate populations (33).

7. Recent safety concerns: the chronicle of events

Although some isolated cases of side effects had been described in UK and Australia (34), Japan was the first country reporting on several girls suffering from severe pain and disability; these cases were heavily publicised in newspapers, TV news and social media, but they also alarmed the medical community. Japanese physicians published later on a series of 44 girls who were diagnosed with complex regional pain syndrome(CRPS) (35). Due to these concerns, in June 2013 the Japanese Ministry of Health, Labour, and Welfare (MHLW) decided to suspend its active recommendation of HPV vaccination. This decision created intense debate among scientists and general public, which continues until nowadays (34).

In March 2015, Denmark‘s TV channel TV2 aired a documentary entitled The Vaccinated Girls – Sick and Betrayed. The journalists gathered about 60 girls from all over Denmark who became sick shortly after receiving the HPV vaccine. Among the doctors interviewed is Louise Brinth, who examined approximately 80 girls with similar symptoms potentially caused by the HPV vaccine. Dr. Brinth noted that the girls experience symptoms such as dizziness, passing out, and severe headaches. She said, “They have abdominal pain and nausea. They have weird muscle movements they cannot control. And they’re very tired… We see a pattern that screams to heaven, and that should be examined by some solid research.”

In April 2015, Dr. Brinth reported in a scientific journal on 53 patients complaining of orthostatic intolerance, severe headache, excessive fatigue, cognitive dysfunction, gastrointestinal discomfort and widespread pain. Most of them were diagnosed with a rare syndrome known as postural orthostatic tachycardia syndrome (POTS), and all of them were in close temporal association with the HPV vaccine (36a, 36b).

Denmark’s documentary has had a huge impact worldwide, both in the general public and the medical community. A closed Facebook page set up for suspected victims of adverse reactions to Gardasil in Denmark tripled its -careful verified- members; similar Facebook groups were created in other countries.

At the request of Denmark, The European Medicines Agency (EMA) is currently conducting a safety review of HPV vaccines. However, the agency emphasizes that this review “does not question that the benefits of HPV vaccines outweigh their risks.”The agency also notes that while the review is being carried out, no change in the use of these products is recommended. See the EMA’s review conclusions here.

Mrs Ryalls reported Emily’s symptoms to the Medicines and Healthcare Products Regulatory Agency (MHRA), and she was not alone: adverse reactions after HPV vaccination numbered 8,228, of which 2,587 were classified as “serious”; that’s substantially more that those reported with other compulsory vaccines (see graph). The MHRA, though, said it had no concerns on the numbers of adverse reactions related to the HPV vaccine and that the “expected benefits in preventing illness and death from HPV infection outweigh the known risks”.

As stated by the newspaper “This article created significant debate among medical professionals, journalists and members of the public…”.

In France, the National Security Agency of Medicines and Health Products (ANSM) just published (September 2015) the results of the follow-up of more than 2 million girls aged 13-16 years, vaccinated between 2008 and 2013 to evaluate the occurrence of side effects, mainly autoimmune diseases. When analysed all the diseases together, their results showed no overall increased risk of occurrence of serious events. However, when each disease was analysed individually, a four-fold increase in the occurrence of Guillain Barre syndrome was observed. The study also found an increased risk of Inflammatory Bowel disease, but the association was weak.

The authors conclude: “…the results of the study… prove reassuring regarding the risk of autoimmune disease associated with the HPV vaccines. The expected benefits of this vaccination in terms of public health are far greater than the eventual risks the girls may be exposed to” (37). In spite of these “reassuring” results, the vaccination rate in France continue to be low (less than 30%).

In September 2015, another report provided details on 45 individuals from 13 countries who developed a chronic ailment soon after receiving the HPV vaccine. “A disabling syndrome of chronic neuropathic pain, vexing fatigue, and profound autonomic dysfunction may appear after HPV vaccination,” say the authors, headed by Manuel Martínez-Lavín, MD, a specialist in chronic pain conditions from Mexico City. After a mean period of 4 years following HPV vaccination, 93% of individuals “continue to have incapacitating symptoms and remain unable to attend school or work,” write the authors (38).

POTSafter HPV vaccination has also been reported in the United States. Dr. Blitshteyn, a neurologist from New York, described six patients who developed POTS between 6 days and 2 months after HPV vaccination. All patients reported improvement over 3 years, but residual symptoms persisted (39).

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) emphasised that controlled clinical trials in tens of thousands of individuals plus postlicensure monitoring of millions of individuals have found no causal association between HPV vaccination and atypical pain syndromes or autonomic dysfunction.

Dr. Diane Harper, an american obstetrician & gynecologist, is one of the HPV experts called in to design the clinical trials of Gardasil and Cervarix. Although initially in favour of the vaccine, in recent years she has questioned Gardasil safety. She stated that “Gardasil has been associated with at least as many serious adverse events as there are deaths from cervical cancer developing each year”. Moreover, in an article published in December 2009 she concluded that, given the various limitations and risks of the vaccines, the beneﬁts and risks of HPV vaccination must be weighed with the beneﬁts and risks of HPV screening (Pap smears) to reduce cervical cancer in a cost-effective manner (40).

Dr. Harper does not support mandatory HPV vaccination for schoolchildren, because she believes that the duration of protection may be too short (see below). She has also criticised the short period of time vaccines were tried before its licensure, and the misleading publicity carried out by the pharmaceutical companies. Learn more here.

8. Other debatable issues

Vaccination in boys

The rationale of vaccinating boys is to reduce the transmission of the HPV virus to women and to protect them against oral and anal cancers (41). Since these cancers are very rare, it has been questioned by some scientists whether is it worth to expose millions of boys to potential vaccine side effects in order to protect girls, or to prevent a so rare type of cancer (responsible for just 300 deaths in the USA); whether the benefit outweighs the risk and if men vaccination is cost effective. While countries such as Australia and the USA include boys in their vaccine recommendations, other countries (i.e., UK and France) have not yet adopted this measure.

Men who have sex with men are a special category, since they are at higher risk of anal cancer. Thus, some experts believe these men (and not every boy) should be offered the vaccine. However, this measure may be difficult to implement: in order get covered by their insurance or social security, young men may be required to declare their sexual preferences.

Immunogenicity of Gardasil vs. Cervarix

Immunogenicity means the ability of the vaccine to provoke an immune response; in other words, the “strength” of the vaccine.

Most countries adopted vaccination with Gardasil instead of Cervarix assuming equal protection for cancer, with the “bonus” protection against genital warts. But is it really like this?

Several studies have demonstrated that Cervarix elicits stronger and longer-lasting immune response than Gardasil (42, 43).

These laboratory findings have also been confirmed by some clinical studies: Over the years, the efficacy of the Cervarix to protect vaccinated women from precancerous lesions (total vaccinated cohort-naive) was 93%, while Gardasil’s dropped to 43% (44)

Age of vaccination

This subject has also raised intense debate and concern. As stated above, immune response provoked by the vaccines may be of limited duration, especially for Gardasil. This can be a serious limitation of the vaccine because, as Dr. Harper noted “… if the HPV vaccine does not last for at least 15 years, no cancers will ever be prevented; women will just get the cancers at a later time in life after the vaccine has worn off“.

If this short protection span is confirmed by clinical studies, a boost dose would solve this limitation. However, this would increase considerably the cost of the vaccine; moreover, women who don’t comply with this recommendation will become unprotected over time.

Increase of promiscuity?

Many people feared that the the HPV vaccine would lead girls to promiscuous behavior. This was actually investigated by some studies, and have proved not to be true: no increase in sexually transmitted diseases was observed among vaccinated girls (45), showing that vaccination is unlikely to promote unsafe sexual activity.

9. Unanswered questions…

In light of the latest publications, should vaccination programs be halted until the situations is clarified?

Due to these latest concerns, will more women opt for no vaccination, missing the opportunity to be protected against cancer?

Since the syndromes potentially related to vaccines are difficult to diagnose, is it possible that they have been underreported in the past? Could they possibly become over reported in the future?

Will the vaccine create a false sense of full protection against cervical cancer, resulting in less women attending screening programs?

Will the vaccine lead to a reduction of the HPV types included in the vaccine, but to an increase of those not included in the vaccine?

10. Conclusion

It is indeed exciting to have a vaccine that protects against cancer. After seeing women dying from cervical cancer, I truly wish that cervical cancer will be eradicated in the future. But we MUST be sure that we don’t create more harm than good in the process.

I am in favor of vaccines. Vaccines have done a lot of good to humanity (just imagine if we would still have small pox, or poliomyelitis…). It is true that every single medical practice may come with side effects, and this include vaccines. But we MUST know exactly what are the vaccine risks, and whether the benefits outweigh the risks.

I firmly believe that governments, scientific societies and pharmaceutical companies MUST do an effort to inform people in a responsible and honest manner, so that all of us -young people, parents and physicians- continue to believe in good science, and vaccines don’t lose their credibility.

It will take 10 to 20 years to figure out the true benefit of the HPV vaccine. In the meantime, keep in mind that Pap tests never killed anyone, on the contrary, they have saved millions of lives. Therefore, don’t forget your Pap smear!